MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005004S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber 5mm4cm 90 percutaneous angioplasty (pta) balloon catheter did not inflate during a pta shunt procedure.The device was replaced with a same size unknown balloon catheter to complete the procedure.No injury was reported to the patient.The device was delivered to the lesion, however pressure did not rise and the balloon did not inflate.The physician is unclear if there was an air leak from the catheter shaft or a balloon rupture.Additional information was requested but not provided.The device was returned for evaluation.Addendum: per product evaluation, results show the balloon leakage was caused by a rupture on the balloon surface.

Manufacturer Narrative

As reported, the balloon of a saber 5mm x 4cm 90 percutaneous angioplasty (pta) balloon catheter did not inflate during a pta shunt procedure.The device was replaced with a same size unknown balloon catheter to complete the procedure.No injury was reported to the patient.The device was delivered to the lesion; however, pressure did not rise, and the balloon did not inflate.The physician is unclear if there was an air leak from the catheter shaft or a balloon rupture.Additional information was requested but not provided.The product was returned for analysis.A non-sterile saber 5mm x 4cm 90 percutaneous transluminal angioplasty was received for analysis inside a plastic bag.Per visual analysis, no physical characteristics were observed by the naked eye.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the saber and pressure was applied.A balloon leakage was observed on the proximal area of the balloon.No other anomalies were observed.Per microscopic analysis, sem analysis was performed.Results showed that the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82202850 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - unable to inflate¿ and subsequent findings of ¿balloon burst¿ were confirmed via device analysis.However, the exact cause cannot be determined.A leakage was noted during functional analysis due to a rupture on the balloon surface.The outer surface of the balloon presented evidence of scratch marks adjacent to the balloon rupture.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.It is likely vessel characteristics and procedural factors contributed to the event reported as evidenced by the analysis provided.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and therefore, often resistant to balloon expansion increasing the likelihood of damage to the balloon.According to the warnings in the safety information in the instructions for use ¿the balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER 5MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13841193
• MDR Text Key: 291238821
• Report Number: 9616099-2022-05470
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068649
• UDI-Public: (01)20705032068649(17)230831(10)82202850
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 48005004S
• Device Catalogue Number: 48005004S
• Device Lot Number: 82202850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BALLOON CATHETER